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U.S. Department of Health and Human Services

Product Classification

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Device vibrator for climax control of premature ejaculation
Regulation Description Vibrator for climax control of premature ejaculation.
Definition Vibrator for climax control training for the treatment of premature ejaculation.
Physical State The device consists of a vibrator connected to a battery pack.
Technical Method Battery-operated vibrator and lubricant for climax control of premature ejaculation for men
Target Area Male genitals
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePIA
Premarket Review Office of Device Evaluation (ODE)
Division of Reproductive, Gastro-Renal, and Urological Devices (DRGUD)
Urology and Lithotripsy Devices Branch (ULDB)
Submission Type 510(k)
Regulation Number 876.5025
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible